FDA.reportPublic FDA data

Aveeno Baby Bathtime Solutions Baby and Me Gift Set

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:50:17

Label at a glance#

ProductAveeno Baby Bathtime Solutions Baby and Me Gift Set
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin

Dosage and administration

Apply as needed.

Storage and handling

To open, twist off cap and remove quality seal. Do not use if quality seal is broken. Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed.

Other information

STORAGE AND HANDLING SECTION

  • To open, twist off cap and remove quality seal. Do not use if quality seal is broken.
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin

Questions?

OTC - QUESTIONS SECTION

866-428-3366; Outside US dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno®

baby

bathtime

solutions

baby and me

gift set

Includes: Daily Moisture Wash & Shampoo 8 fl oz

(236 mL), Daily Moisture Lotion 8 oz (227 g),

CALMING COMFORT® Bath 8 fl oz (236mL) and

Stress Relief Body Wash 12 fl oz (354 mL)

Aveeno_01Aveeno_01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0756-92024-01-30C16284748780-11030e365-376b-111a-e063-dadaa90a10e2Aveeno® baby bathtime solutions baby and me gift set AVEENO® Baby Daily Moisture Lotion

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0679AVEENO BABY BATHTIME SOLUTIONS BABY AND ME GIFT SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]5Current NDC, Legacy NDC20241108_dceca111-5dae-557b-e053-2995a90a3fa0.zip
69968-0756AVEENO BABY BATHTIME SOLUTIONS BABY AND ME GIFT SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]5Legacy NDC20241108_dceca111-5dae-557b-e053-2995a90a3fa0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-075669968-0756-9
69968-067969968-0679-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATZ6J799EAJKIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALLANTOIN344S277G0ZIACT
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
GLYCERINPDC6A3C0OXINGR
COCO GLUCOSIDEICS790225BINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM BENZOATEOJ245FE5EUINGR
GLYCERYL OLEATE4PC054V79PINGR
SODIUM HYDROXIDE55X04QC32IINGR
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AINGR
OATZ6J799EAJKINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM BENZOATEOJ245FE5EUINGR
GLYCERYL OLEATE4PC054V79PINGR
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YINGR
SODIUM HYDROXIDE55X04QC32IINGR
OATZ6J799EAJKINGR
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
GLYCERINPDC6A3C0OXINGR
COCO GLUCOSIDEICS790225BINGR
OATMEAL8PI54V663YINGR
GLYCERINPDC6A3C0OXINGR
WATER059QF0KO0RINGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4637351b-6259-f632-e063-6394a90a8359dceca111-5dae-557b-e053-2995a90a3fa02025-12-18WarningsExact identifier
spl set id: dceca111-5dae-557b-e053-2995a90a3fa0
Aveeno Baby Welcome Little One Gift BasketDIMETHICONEKenvue Brands LLCe05e3c63-1691-7a86-e053-2a95a90a6bcb2024-11-06WarningsExact identifier
ndc (package): 69968-0679-8
ndc11 (package): 69968067908
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
ndc (package): 69968-0679-8
ndc (product): 69968-0679
ndc11 (package): 69968067908

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.